Covaxin efficacy over 77% efficacy in phase 3 trials

The story: Bharat Biotech’s Covaxin, India’s first indigenous vaccine against Covid-19, showed a 77.6 per cent efficacy in the final analysis of phase

Covaxin efficacy over 77% efficacy in phase 3 trials

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• The story: Bharat Biotech’s Covaxin, India’s first indigenous vaccine against Covid-19, showed a 77.6 per cent efficacy in the final analysis of phase 3 clinical trials. This was a long awaited result, that had turned controversial over time.
• Details: The vaccine showed an efficacy rate of 93 per cent against severe disease and 60 per cent against asymptomatic Covid-19. The Hyderabad-based vaccine manufacturer sought a full marketing authorisation for Covaxin after the final analysis of phase 3 data before the Subject Expert Committee (SEC), which advised the Drugs Controller General of India (DCGI).
1. More data on safety was sought from the company before a full authorisation can be granted
2. Now that the data from phase 3 trials has been reviewed by the drug regulator of the country of origin, the firm can present it before the World Health Organization (WHO)
3. Bharat Biotech is set to present the data before the WHO as it seeks to be part of the WHO-Emergency Use List (EUL)
• Worries mitigated: Once Covaxin features in the WHO-EUL, it would address concerns around those vaccinated with this jab travelling abroad as most countries are allowing travelers who are vaccinated by one of the doses that feature in the list. Bharat Biotech indicated that it was engaging with the WHO and presenting data from the analysis of trials from time to time. The company has said it expects a WHO nod between July and September.

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